Kornimate/medical-research-clean huggingface dataset:
review of safety using rilonacept in preventing gout exacerbations (re-surge)

Conditions: Gout

Summary: the purpose of this clinical research study is to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are on urate-lowering therapy. subjects will participate in this study for approximately 20 weeks. rilonacept is being studied for use in preventing gout flares in subjects on urate-lowering therapy.


Eligibility criteria:
inclusion criteria: * male or female 18 to 80 years of age; * previously met the preliminary criteria of american rheumatism associatio (ara) for the classification of acute gout arthritis of primary gout; * subjects with history of gout, initiating or currently on urate lowering; therapy who are at risk of gout flare. exclusion criteria: * acute gout flare within 2 weeks prior to the screening visit and during the screening visit; * persistent chronic or active infections; * history of an allergic reaction to allopurinol; * history or presence of cancer within 5 years of the screening visit;;;

Keywords: metabolism, inborn errors allopurinol metabolic disease genetic diseases, inborn musculoskeletal diseases joint diseases arthritis rheumatic diseases metabolic disorder purine pyrimidine metabolism, inborn errors gout intercritical gout
a study using 18f-fapi pet to evaluate treatment response in pancreatic adenocarcinoma

Conditions: 18F-FAPI; Pancreas Adenocarcinoma; Systemic Treatment; Pathologic Response

Summary: to explore the potential utility of 18f-fapi-04 pet/ct for pathologic response evaluation to systemic treatment in pdac


Eligibility criteria:
inclusion criteria: * suspected to have pancreatic cancer by radiological imaging * planned systemic treatment * possibility of conversion surgery * willingness to participate the study exclusion criteria: * without pathologically confirmed pancreatic cancer * poor performance status or organ functions that cannot meet the systemic treatment requirements * metastatic disease * pregnant patients
targeting osteosarcopaenia and multimorbidity for frailty prevention

Conditions: Stroke; Traumatic Brain Injury; Knee Osteoarthritis; Breast Cancer

Summary: the aging population and its accompanying burden from non-communicable chronic diseases predicts an increasing impact imposed by frailty on healthcare systems. this is due to a lack of normative data for older adults and reliable risk stratification methods to develop effective approaches to the prevention of frailty. in this study, the investigators plan to form a common dataset for phenotype identification, risk stratification of frailty and its targeted treatment plans in the at-risk and mildly frail population.

osteosarcopaenia and multimorbidity have emerged as two key antecedent factors driving the cycle of frailty, leading to adverse outcomes. however, it remains unclear how multimorbidity and/or osteosarcopaenia act singly or in concert to influence the expression and trajectory of the frailty continuum. optima-c will develop unifying administrative and data platforms, exploring the feasibility of inclusive screening for sarcopaenia early during rehabilitation hospital stay. early muscle ultrasound will also be utilised to determine key muscles possibly predictive of rehabilitation functional or global outcomes in the studied populations and their correlation with acute disease outcomes. digital markers are quantified and correlations are investigated with physical, muscle and bone imaging findings.

Eligibility criteria:
inclusion criteria: 1. age ≥ 50y 2. asian ethnicity 3. first diagnosis (stroke, traumatic brain injury (tbi), knee osteoarthritis, breast cancer) 4. living in community 5. able to understand 1 step simple commands 6. for inpatients: (i) within 12 weeks of disease (stroke/tbi) onset, and (ii) within 2 weeks of rehabilitation ward admission 7. for outpatients: (i) \>6 months from initial diagnosis of first stroke, tbi, knee osteoarthritis or breast cancer, and (ii) at least standby assistance, modified independent or independent in ambulation with /without walking. exclusion criteria: 1. nursing home or dormitory resident 2. non-resident status in singapore (e.g. foreign worker, tourist, temporary visit pass) 3. impairments affecting understanding of questionnaires and tasks: e.g. severe deafness, severe visual impairment and severe /global aphasia, 4. presence of active fractures, dislocations, non-weight bearing status, burns, unhealed wounds, active skin infections/eczema and agitated behaviour or delirium 5. anticipated life expectancy \< 1 year 6. presence of tracheostomy, ventilator, renal dialysis, end-organ failure 7. patients with disorders of consciousness. 8. pregnant or lactating participants for knee osteoarthritis patients only: 9. alternative diagnosis to knee oa e.g. referred pain from hip or spine. 10. other forms of knee arthritis eg. inflammatory, post traumatic 11. previous knee arthroplasty

Keywords: frailty multimorbidity osteosarcopaenia
effect of activities and exercise on sleep in elderly persons with dementia

Conditions: Dementia; Elderly; Sleep

Summary: the purpose of the study is to determine whether individualized social activities, physical resistance training and walking, and a combination of both are effective in improving nighttime sleep in elders with dementia.

elders with cognitive impairment usually do not a get a good night's sleep and wake up often during their sleep at night. increased daytime individualized social activity and physical resistance training with walking have the potential to increase nighttime sleep in elders. this can lead to a better quality of life, a decrease in caregiver burden and decrease in nighttime falls for this population and associated fiscal savings. consent forms for this rct, were written in large print, followed all the guidelines of the institutional review board of the university of arkansas for medical sciences, and assured the participants that their participation in the study was voluntary.

Eligibility criteria:
inclusion criteria: * age 55 years old or older * mini mental state examination (mmse)of 4-26, indicating dementia or mild cognitive impairment * less than seven hours of nocturnal sleep and 30 minutes of daytime sleep * at least two weeks residency in the nursing home * medical diagnosis of dementia; and * ability to stand with assistance exclusion criteria: * documented near-terminal or unstable medical conditions * unresolved malignancy * treatment with chemotherapy; and * unstable cardiovascular disease
effectiveness of individualized automatic coaching message for glycemic management and depressive symptom

Conditions: Diabetes Mellitus Type 2; Continuous Glucose Measurement; Depressive Symptom

Summary: this is a 12-week, single-center, randomized, prospective, confirmatory study of effectiveness of the individualized automatic coaching messages for glycemic management based on continuous glucose monitoring and depressive symptom in insulin-treated patients with type 2 diabetes.

this study will enroll patients with type 2 diabetes who are insulin-treated outpatient care at the department of endocrinology and metabolism, samsung medical center. for 12 weeks, both intervention and control groups will apply continuous glucose monitoring system. the intervention group will receive weekly personalized coaching messages for glycemic management based on data from continuous glucose monitoring and bi-weekly personalized coaching messages for depressive symptoms based on depression questionnaires. the control group will not receive the coaching messages. the aim of this study is to evaluate whether the efficacy of individualized automatic target coaching messages based on continuous glucose monitoring metrics and depressive symptom assessments is superior to those who do not receive the messages in insulin-treated patients with type 2 diabetes.

Eligibility criteria:
inclusion criteria: * patients for whom the use of a continuous glucose monitor has been determined based on the medical judgment of the attending physician. * insulin-treated type 2 diabetes patients, age 18-80 years old. * patients who have not changed their diabetes medication in the past 2 months. * patients with a glycated hemoglobin level between 6.5% and 12.0% within the last 3 months. * patients currently receiving insulin injection therapy, including basal insulin. * patients who have access to kakaotalk via smartphone and are able to communicate with it. * voluntarily agreed to participate in this clinical study. exclusion criteria: * steroid and immunosuppressant users. but it can be included if patients continuously maintain same drug dose at least three months. * patients who are currently taking weight control medications. * breastfeeding or pregnant patients * patients who do not voluntarily consent to the study * anyone deemed unsuitable by the investigator to participate in the study

Keywords: behavioral symptom glucose metabolism disorders endocrine system diseases diabetes mellitus, type 2 continuous glucose monitoring depression diabetes mellitus metabolic diseases
reading ability in childhood obesity

Conditions: Obesity, Childhood; Obesity, Adolescent

Summary: there is some evidence about the negative impact of overweight and obesity on reading ability, with negative consequences on quality of life and school success. in this neuropsychological research, the relationship between the characteristics of reading abilities in individuals with obesity (age range between 11 and 16 years) and the skills of motor coordination, postural stability, manual dexterity, including graphomotor skills, and estimation of time is investigated according to the cerebellar deficit theory.


Eligibility criteria:
inclusion criteria • diagnosis of overweight or obesity exclusion criteria: • concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders.

Keywords: reading abilities cognitive functioning neuropsychological assessment motor abilities
the inland norway healthy life center study

Conditions: Non-Communicable Chronic Diseases; Obesity; Insulin Resistance; Musculoskeletal Diseases; Psychological Disorder; Cardiovascular Diseases

Summary: healthy life centers (norwegian, 'frisklivssentralen') is a municipal service in norway that aims to promote both physical and mental health, as well as to limit the development of non-communicable diseases. previous research has shown that receiving follow-up from healthy life centers has led to higher levels of daily physical activity, in addition to improved self-reported health and quality of life among the participants. however, there is a lack of studies that have examined what kind of physiological health effects can be expected from participating in the healthy life center's follow-up. in this study, responses to the 12-week physical activity program of the healthy life center will be compared with the responses in a negative control group that does not receive such follow-up. both the intervention group and the reference group (the negative control group) will carry out the same tests and measurements before and after the 12 week period. the tests will include measurements of anthropometric variables (body height, body weight and waist circumference), body composition, arterial stiffness, resting blood pressure and blood variables (blood glucose, long-term blood glucose, blood lipid profile and inflammation markers), in addition to physical tests of mobility, balance, maximum aerobic capacity (maximal oxygen consumption) and maximum muscle strength. questionnaires related to adherence to the healthy life center follow-up, socio-demographic variables, eating and drinking habits, activity level, perceived physical fitness, motivation for exercise, and health-related quality of life will also be included.


Eligibility criteria:
intervention group inclusion criteria: * \>18 years of age * receiving follow-up from the healthy life center exclusion criteria: * in average \>1 weekly exercise training session the last three months reference group inclusion criteria: * \>18 years of age exclusion criteria: * in average \>1 weekly exercise training session the last three months * receiving follow-up from the healthy life center
analysis of markers in the blood correlated with neuropathic pain

Conditions: Neuropathy

Summary: the purpose of this study is to analyze associations between symptoms and specific markers in the blood in patients suffering from neuropathic pain linked to diseases of different origin. such markers could be utilized in the future for precise diagnosis of neuropathic pain and might lead to targeted pain treatment.

on average, 3-8% of the german population suffers from neuropathic pain, which can occur after damage of somatosensory nerves in the peripheral or central nervous system. in terms of a "personalized" medicine, only a strict separation of neuropathic and chronic pain allows an individualized therapy to reduce pain severity and to enhance patients' quality of life. currently, the diagnosis of neuropathic pain is based on the medical history, the subjective description of somatosensory symptoms and the application of (non-genetic) diagnostic tests. to improve diagnosis and therapy of complex disorders for individual patients, novel methods are introduced based on flow cytometric (facs) analysis of human immune cells or analysis of the human genome (genomics). those techniques can support the identification of characteristic features indicating ongoing individual pathophysiologic processes in the body (biomarkers). often diseases are based on a complex relationship between genetics, environmental factors and the manifestation of the disease. to capture this complexity via genomics, phenotypical and genotypical data of high quality and detailed information about the study population are required. this observational study includes patients suffering from painful and non-painful neuropathies associated with hiv-infection, diabetes mellitus and breast cancer. with the targeted application of validated questionnaires (such as the brief pain inventory, pain catastrophizing scale, hospital anxiety and depression scale, ten-item personality inventory, 36-item short form health survey, and the insomnia severity index) and parallel usage of genomics or facs analysis of selected biomarkers in the blood, this study will provide information about the manifestation of certain genes or immune markers which are directly correlated to the symptoms of the disease. additional performance of neuropsychological/cognitive tests and quantitative sensory testing (qst) will enhance the phenotypic profile. identification of potential indicators could be utilized prospectively to precisely diagnose and effectively treat neuropathic pain.

Eligibility criteria:
inclusion criteria: * hiv-associated neuropathy * sufficient knowledge of the german language exclusion criteria: * co-incident severe central nervous system diseases * major psychiatric conditions * dementia * limited mental capacity or limited german language skills * intoxication with alcohol or recreational drugs within the last 48 hours of the study

Keywords: neuropathic pain phenotype genotype biomarkers hiv diabetes mellitus breast cancer genomics quantitative sensory testing
a guided online act intervention combined with psychoeducation for people with spinal cord injury

Conditions: Spinal Cord Injuries; Psychological Distress

Summary: the purpose of this preliminary study is to examine the effects of a guided online acceptance and commitment therapy (act) intervention combined with psychoeducation on people with spinal cord injury (sci) who experience psychological distress.

this project will employ a one-group pretest-posttest design to investigate the effects of a guided online acceptance and commitment therapy (act) intervention combined with psychoeducation on quality of life and mental health of people with spinal cord injury (sci) who experience psychological distress. after the pretest evaluation, eligible participants will receive 8 weekly sessions, including 6 act sessions and 2 psychoeducation sessions, delivered by trained coaches through zoom videoconferencing. each session lasts for one hour. primary outcome measures will be psychological distress measured by the depression, anxiety and stress scale (dass)- 21 and spinal cord injury - quality of life (sci-qol). a one-time interview at the completion of the 8 sessions will be conducted to explore participants' experiences in the sessions.

Eligibility criteria:
inclusion criteria: * community-dwelling adults (age 18 or over) living in the community who had a spinal cord injury * suffering at least mild symptoms of psychological distress measured by the dass-21 * having a computer/smartphone with internet access capable of doing web browsing and video-conferencing * being able to provide informed consent by understanding the nature of study participation. exclusion criteria: * having cognitive, physical, or sensory deficits, or language barriers (non- english communicator) that impede study participation * receiving a psychological therapy currently * having psychiatric hospitalizations or diagnoses of mental illness in the previous 2 years * taking antipsychotic or anticonvulsant medication at the time of recruitment * having the possibility of study dropouts due to other medical conditions

Keywords: acceptance and commitment therapy quality of life spinal cord injury psychological distress depression anxiety stress mindfulness self-compassion
dose-escalation by hypofractionated stereotactic radiotherapy for brain metastases in non small cell lung cancer

Conditions: Non Small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer; Brain Metastases

Summary: the objective of this trial is to assess the safety and feasibility of delivering sbrt to patients with limited bms (less than 10 lesions of lung cancer) by establishing the maximally tolerated dose (mtd) of sabr in 5 fractions.

the objective of this trial is to assess the safety and feasibility of delivering sbrt to patients with limited bms (less than 10 lesions of lung cancer) by establishing the maximally tolerated dose (mtd) of sabr in 5 fractions.

Eligibility criteria:
inclusion criteria: * histology confirmed that it was non-small cell lung cancer * 1 to 10 brain metastases detected by magnetic resonance imaging (mri) * a life expectancy of \>3 months according to the ds gpa. * kps ≥70 * control of the primary lesions (thorax) at the time of sbrt * 2cm\<tumor size ≤ 4 cm * age of 18-75 years old * patients must be able to undergo contrast enhanced mri for planning * adequate bone marrow and organ function exclusion criteria: * other malignant tumors * prior surgery to brain metastasis * prior brain radiotherapy * non-small cell lung cancer with more than 10 brain metastases detected by mri * contraindication to receiving radiotherapy.

Keywords: lung cancer brain metastases hypofractionated stereotactic radiotherapy
acute and subacute iliofemoral and/or caval deep vein thrombosis: evaluation of mechanical thrombectomy systems

Conditions: Thrombosis, Venous

Summary: this is a physician-initiated, observational, monocentric, retrospective and prospective study. the study is intended to assess the feasibility of mechanical thrombectomy of caval and iliofemoral veins according to normal clinical practice in adult patients with symptomatic acute or subacute ileofemoral or caval deep vein thrombosis objectively diagnosed with ct scan imaging.

subjects with bilateral dvt may be enrolled, so long as the study limb(s) meet inclusion/exclusion criteria, including ivc patency. it is recommended that in a subject with bilateral dvt, central imaging be performed prior to treatment to evaluate the status of the ivc. all the visits and procedures described will be performed according to the diagnostic and therapeutic assignment required by clinical practice for the patients under study. therefore, the choice of assigning the patient to the diagnostic and therapeutic procedures deemed most appropriate for each case is completely independent of the study. anticoagulation therapy with enoxaparin sodium (1 mg/kg twice a day) shall be initiated at least 48 hours prior to initiation of study treatment. hemoglobin, inr, and platelet count must be obtained within 24 hours prior to the mechanical thrombectomy procedure in order to confirm eligibility. the access site is determined by the extent of occlusive disease. when treating a single limb at time, access via the popliteal vein is reasonable. upon completion of study treatment, the catheter and sheath shall be removed and hemostasis obtained with pressure over the insertion site followed by placement of a pressure dressing. pcb shall remain placed on both legs until hospital discharge. anticoagulation therapy with weight based enoxaparin sodium shall also be continued through discharge. the following assessments should be performed following the completion of study treatment, according to the normal clinical practice: * duplex imaging (within 24 hours of the completion of treatment) * laboratory tests (within 24 hours of the completion of treatment) * collection of adverse events

Eligibility criteria:
inclusion criteria: all patients admitted in the unit of vascular surgery with proximal dvt (inferior vena cava, and/or iliac vein, and/or common femoral vein, and/or deep femoral vein, and/or femoral vein), according to esvs guidelines (2022). exclusion criteria: * patient treated with thrombolysis drugs within 48 hours prior to the index procedure * active bleeding, recent (\<3 months) gastrointestinal (gi) bleeding, active peptic ulcer, severe liver dysfunction, and bleeding diathesis * impossibility or refusal to give informed consent